Table 3. Adverse events (any grade; any cause) occurring in ≥20% of patients in either arm or grade ≥3 events (any cause) occurring in ≥3 patients.
| Adverse event | Number of patients, n (%) | |||||||
|---|---|---|---|---|---|---|---|---|
| Barasertib 1200 mg(n=48) | LDAC 400 mg(n=26) | |||||||
| All grades | Grade 3 | Grade 4 | Grade 5 | All grades | Grade 3 | Grade 4 | Grade 5 | |
| Stomatitis/mucositis | 37 (77) | 14 (29) | – | – | 6 (23) | – | – | – |
| Febrile neutropenia | 32 (67) | 23 (48) | 1 (2) | – | 6 (23) | 5 (19) | – | – |
| Diarrhea | 24 (50) | 2 (4) | – | – | 3 (12) | – | – | – |
| Constipation | 22 (46) | – | – | – | 8 (31) | – | – | – |
| Nausea | 21 (44) | 1 (2) | – | – | 10 (39) | – | – | – |
| Vomiting | 16 (33) | – | – | – | 5 (19) | – | – | – |
| Pyrexia | 13 (27) | – | – | – | 8 (31) | – | – | – |
| Pneumonia/lobar pneumonia | 12 (25) | 7 (15)* | – | 4 (8) | 2 (8) | 1 (4)* | – | 1 (4) |
| Alopecia | 11 (23) | – | – | – | 0 | – | – | – |
| Epistaxis | 11 (23) | – | – | – | 6 (23) | – | – | – |
| Anemia | 10 (21) | 1 (2) | 6 (13) | – | 4 (15) | 4 (15) | – | – |
| Decreased appetite | 10 (21) | – | – | – | 5 (19) | – | – | – |
| Insomnia | 10 (21) | – | – | – | 3 (12) | – | – | – |
| Rash | 10 (21) | – | – | – | 2 (8) | – | – | – |
| Fatigue | 9 (19) | – | – | – | 6 (23) | – | – | – |
| Thrombocytopenia | 9 (19) | 1 (2) | 6 (13) | – | 5 (19) | – | 4 (15) | – |
| Back pain | 8 (17) | – | – | – | 2 (8) | – | – | – |
| Dyspnea | 8 (17) | 1 (2) | – | – | 5 (19) | 3 (12) | 1 (4) | – |
| Hypokalemia | 8 (17) | – | – | – | 2 (8) | – | – | – |
| Asthenia | 7 (15) | – | – | – | 8 (31) | – | – | – |
| Neutropenia | 7 (15) | 4 (8) | 3 (6) | – | 2 (8) | – | 2 (8) | – |
| Edema peripheral | 7 (15) | – | – | – | 7 (27) | – | – | – |
| Leukopenia | 6 (13) | 1 (2) | 5 (10) | – | – | – | – | – |
| Cellulitis | 4 (8) | 4 (8) | – | – | – | – | – | – |
| Lymphopenia | 4 (8) | 1 (2) | 3 (6) | – | – | – | – | – |
| Sepsis | 4 (8) | 3 (6) | 1 (2) | – | – | – | – | 1 (4) |
| Hyponatremia | 3 (6) | 3 (6) | – | – | 1 (4) | 1 (4) | – | – |
Classified as pneumonia only. Stomatitis/mucositis includes oral pain, oropharyngeal pain, mouth ulceration, tongue ulceration, gingivitis, and aphthous stomatitis. Febrile neutropenia includes neutropenic infection, febrile bone marrow aplasia, and neutropenic sepsis